Articaine Efficacy and Safety for Children Below Age of 4-years

Minia University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pain; Behaviour Assessment

Treatments: Drug: lidocaine hydrochloride 2% and epinephrine 1:100000; Drug: Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml

Study type: Interventional

Funder types: Other

Identifiers

NCT04061265

245

Details and patient eligibility

About

Pain control is one of the significant behavior determinants in the dental office and shaping the future attitude toward dentistry, especially in children. One of widely used local anesthetic agents is articaine hydrochloride because of its superior potency, over traditionally used 2% lidocaine. Therefore, this study intends to get the benefits of articaine efficiency and apply it in children.

Enrollment: 184 patients

Sex: All

Ages: 37 to 47 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged 36-47 months. ASA I, II. Mentally capable of communication. Having a mandibular primary molar tooth that required extraction or pulpotomy.

Exclusion criteria

• The presence of infection, which may compromise the efficiency of local anesthetic agent Significant behaviour problems Medical or mental unfitness

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

184 participants in 2 patient groups

Lidocaine 2% group

Active Comparator group

Description:

lidocaine hydrochloride 2% and epinephrine 1:100000 (Lignospan® standard, 1.7ml, SEPTODONT Ltd)

Treatment:

Drug: lidocaine hydrochloride 2% and epinephrine 1:100000

Articaine 4%

Experimental group

Description:

articaine hydrochloride 4% and epinephrine 1:100000 (Septocaine® 1.7ml, SEPTODONT Ltd)

Treatment:

Drug: Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml